Angiosarcoma
Conditions
Interventions
Trade Name: propranolol
Product Name: propranolol
Pharmaceutical Form: Tablet
Sponsors
Netherlands Cancer Institute- Antoni van Leeuwenhoek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o Histological proof of angiosarcoma o Patients with primary, recurrent and metastasised disease are eligible; o Age of 18 years or more; o Able and willing to give written informed consent; o WHO performance status of 0, 1 or 2; o Evaluable disease according to RECIST 1.1 criteria; radiologic visible disease is not obligated in patients with cutaneous angiosarcoma o Patients with a window of at least 3 weeks before surgery or systemic therapy; o At least one tumor lesion accessible to safely biopsy per clinical judgement of the treating physician. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: o Contraindication for propranolol therapy, o Current treatment with ß-blockade therapy. o Any anticancer treatment within 30 days prior to receiving the first dose of investigational treatment; with the exception of hormonal therapy for breast cancer. o Concurrent treatment with an anticancer therapy: with the exception of hormonal therapy for breast cancer. opregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical response of propranolol monotherapy in patients with angiosarcoma.;Secondary Objective: To determine the histologic response of propranolol monotherapy in patients with angiosarcoma.;Primary end point(s): The clinical response will be determined in terms of decrease in tumor size on examination, according to RECIST criteria (PR is >30% decrease in size, PD is >20% increase in size, SD is in between while CR is no measurable disease). In patients with cutaneous angiosarcoma, documentation will be performed with color photography, including a ruler to estimate the size of the lesion. Otherwise radiologic assessments will be used to evaluate anti-tumor activity. If propranolol leads to a response in =3 out of 14 patients, this treatment modality is highly interesting and should be tested further in a randomized trial. A response is defined as CR, PR, or SD with an improvement in clinical characteristics, like thickness, erythema, necrosis or edema of the inflicted area in case of clinically evaluable disease (cutaneous angiosarcoma).;Timepoint(s) of evaluation of this end point: weekly evaluation on the outpatient clinic | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The histologic response on propranolol treatment in terms of difference in proliferation index by immunohistochemistry staining of Ki-67 and in tumor activity will be determined between the post-treatment biopsy (obtained during surgery if applicable) and the diagnostic biopsy. A decrease of >30% of Ki-67 staining was stated as a positive histologic response. ;Timepoint(s) of evaluation of this end point: The pretreatment biopsy, obtained during screening, will be compared with the biopsy after the study treatment (after 3-6 weeks of propranolol). | — |
Countries
Netherlands
Contacts
Public ContactN. Steeghs
Netherlands Cancer Institute- Antoni van Leeuwenhoek
Outcome results
None listed